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Childrens Ibuprofen

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Active ingredient
Ibuprofen 100 mg
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Tablet, Chewable
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2019
Label revision date
August 20, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Ibuprofen 100 mg
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Tablet, Chewable
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2019
Label revision date
August 20, 2025
Manufacturer
Meijer Distribution Inc
Registration number
ANDA076359
NDC root
41250-726
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

If you are a consumer or patient please visit this version.

Drug Overview

Ibuprofen is a chewable pain reliever and fever reducer designed for children aged 2 to 11 years. It comes in grape-flavored tablets, each containing 100 mg of ibuprofen, which is a type of medication known as a nonsteroidal anti-inflammatory drug (NSAID). This medication works by reducing fever and relieving minor aches and pains associated with common conditions like the cold, flu, sore throat, headaches, and toothaches.

Each package contains 24 tablets, and the effects can last up to 8 hours. It's important to chew or crush the tablets completely before swallowing to ensure proper absorption.

Uses

You can use this medication to help reduce fever and relieve minor aches and pains. It’s effective for discomfort caused by common conditions like the cold, flu, sore throat, headaches, and toothaches.

This means that if you're feeling under the weather or dealing with everyday aches, this medication can provide some relief to help you feel better.

Dosage and Administration

Before taking this medication, make sure to chew or crush the tablets completely before swallowing them. It's important to follow the dosing instructions carefully, so do not exceed the recommended amount. You can find the right dose by referring to a dosing chart that considers both weight and age. If possible, use weight to determine the dose; if not, age can be used as a guide.

For children under 2 years old who weigh less than 24 pounds, it's best to consult a doctor before giving any tablets. For children aged 2 to 3 years who weigh between 24 and 35 pounds, the recommended dose is 1 tablet. If your child is 4 to 5 years old and weighs between 36 and 47 pounds, they should take 1 ½ tablets. For those aged 6 to 8 years and weighing 48 to 59 pounds, the dose is 2 tablets. If your child is 9 to 10 years old and weighs between 60 and 71 pounds, they should take 2 ½ tablets. Finally, for an 11-year-old weighing between 72 and 95 pounds, the dose is 3 tablets. If needed, you can repeat the dose every 6 to 8 hours, but remember not to use this medication more than 4 times a day.

What to Avoid

It's important to be cautious when considering this medication for your child. You should not use it if your child has ever had an allergic reaction to ibuprofen or any other pain reliever or fever reducer. Additionally, avoid using this medication right before or after heart surgery, as it can pose serious risks in these situations.

Always prioritize your child's safety by following these guidelines closely. If you have any concerns or questions about using this medication, consult with a healthcare professional for personalized advice.

Side Effects

Using ibuprofen can lead to some serious side effects, so it's important to be aware of them. You may experience a severe allergic reaction, especially if you are allergic to aspirin. Symptoms can include hives, facial swelling, wheezing, shock, skin reddening, rash, or blisters. Additionally, ibuprofen can increase the risk of severe stomach bleeding, particularly if you have a history of stomach ulcers, are taking blood thinners or steroids, or use other NSAIDs.

There is also a risk of heart attack and stroke associated with NSAIDs, which can be fatal, especially if taken in higher doses or for longer than recommended. If you notice signs of stomach bleeding, such as feeling faint, vomiting blood, or having black stools, or if you experience symptoms of heart problems like chest pain or trouble breathing, seek medical attention immediately. Always consult your doctor if you have any underlying health conditions or are taking other medications before using ibuprofen.

Warnings and Precautions

Ibuprofen can cause serious allergic reactions, especially if you are allergic to aspirin. Symptoms may include hives, facial swelling, wheezing, shock, skin reddening, rash, or blisters. If you experience any of these symptoms, stop using the medication and seek medical help immediately.

This medication can also lead to severe stomach bleeding, particularly if you have a history of stomach ulcers or bleeding issues, are taking blood thinners or steroids, or are using other NSAIDs (nonsteroidal anti-inflammatory drugs) like aspirin or naproxen. Additionally, using ibuprofen for longer than directed increases the risk of heart attack and stroke, which can be fatal. If you notice signs of stomach bleeding, such as feeling faint, vomiting blood, or having black stools, stop use and contact your doctor right away.

For children, do not use ibuprofen for more than two days without a doctor's guidance, especially if they have a severe sore throat with high fever, headache, nausea, or vomiting. If your child does not feel better within 24 hours, or if symptoms worsen or new symptoms appear, consult a doctor. In case of an overdose, seek emergency medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Overdose

If you suspect an overdose, it’s crucial to seek medical help immediately. You can contact a Poison Control Center at 1-800-222-1222 for guidance. Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing.

Always take overdosing seriously. If you notice any of these symptoms or have concerns about a possible overdose, don’t hesitate to reach out for help right away. Your safety is the top priority.

Pregnancy Use

When considering the use of ibuprofen during pregnancy, it's important to note that the available information does not specify any particular guidelines or risks associated with its use. There are no contraindications (conditions that would prevent its use) mentioned, and no dosage adjustments are recommended for pregnant individuals. Additionally, the text does not highlight any special precautions you should take if you are pregnant.

While this information suggests that ibuprofen may not pose specific risks during pregnancy, it's always best to consult with your healthcare provider before taking any medication. They can provide personalized advice based on your health and pregnancy status.

Lactation Use

When it comes to breastfeeding, it's important to be aware that there are no specific guidelines or statements regarding nursing mothers or lactation (the process of producing milk). This means that if you are breastfeeding, you may not find detailed information about how certain medications or treatments could affect you or your baby.

If you have concerns about breastfeeding while taking any medication, it's always a good idea to consult with your healthcare provider. They can provide personalized advice based on your situation and help ensure the safety and well-being of both you and your infant.

Pediatric Use

It's important to be cautious when giving medication to children. You should not use this medication in children under 3 years of age unless a doctor specifically advises you to do so. For children aged 2 to 11 years, the dosage depends on their weight. For example, if your child weighs under 24 pounds and is under 2 years old, consult a doctor first. As a general guideline, children aged 2-3 years who weigh between 24-35 pounds can take 1 tablet, while those aged 4-5 years and weighing 36-47 pounds can take 1 ½ tablets. Always follow the recommended dosages and do not exceed the maximum of 4 doses in a day.

Before giving this medication, consult a doctor if your child has any history of stomach issues, high blood pressure, heart disease, liver or kidney problems, asthma, or if they are taking a diuretic (a type of medication that helps remove excess fluid from the body). Additionally, seek medical advice if your child is under care for any serious health condition. If your child does not feel better within 24 hours, or if their fever or pain worsens or lasts more than 3 days, contact a healthcare professional.

Geriatric Use

When it comes to using Children’s Ibuprofen for older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that while the medication is generally considered safe, it’s important for you or your caregiver to monitor for any unusual side effects or reactions, especially if there are existing health conditions.

If you have any concerns about using this medication, particularly if you are managing other health issues or taking other medications, it’s a good idea to consult with a healthcare professional. They can provide personalized advice to ensure safe and effective use.

Renal Impairment

If you have kidney problems, it's important to consult your doctor before using this medication. Your healthcare provider needs to know about any existing conditions, such as high blood pressure, heart disease, liver cirrhosis, or a history of stroke, as these can affect how the medication works for you. Always prioritize open communication with your doctor to ensure your safety and the effectiveness of your treatment.

Hepatic Impairment

If you have liver problems, such as liver cirrhosis (severe scarring of the liver), it's important to be aware of how this may affect your treatment. Your healthcare provider may need to adjust your medication dosage or closely monitor your liver function tests (tests that check how well your liver is working) to ensure your safety and the effectiveness of your treatment.

Additionally, if you have other health conditions like high blood pressure, heart disease, or kidney disease, these may also influence your treatment plan. Always communicate openly with your healthcare team about your liver health and any other medical issues you may have.

Drug Interactions

It's important to be aware of how ibuprofen can interact with other medications you may be taking. For instance, if you are using blood thinners (medications that help prevent blood clots) or steroids, taking ibuprofen could increase your risk of stomach bleeding. Additionally, using ibuprofen, especially in higher doses or for extended periods, may raise your chances of experiencing serious heart issues, such as heart attack or stroke. You should also avoid taking ibuprofen alongside other nonsteroidal anti-inflammatory drugs (NSAIDs), like aspirin or naproxen, as this can lead to further complications.

Always discuss your current medications and any lab tests with your healthcare provider. They can help you understand the risks and ensure that your treatment plan is safe and effective.

Storage and Handling

To ensure the safety and effectiveness of your product, store it at a temperature between 20-25°C (68-77°F). This temperature range helps maintain the product's integrity. Before using it, always check that the printed seal under the cap is intact; do not use the product if the seal is broken or missing, as this could indicate contamination or that the product is no longer safe to use.

By following these simple storage and handling guidelines, you can help ensure that the product remains safe and effective for your needs.

Additional Information

No further information is available.

FAQ

What is ibuprofen used for?

Ibuprofen is used to reduce fever and relieve minor aches and pains due to the common cold, flu, sore throat, headaches, and toothaches.

What age group can use Meijer CHILDREN’S ibuprofen?

Meijer CHILDREN’S ibuprofen is for children ages 2 to 11 years.

How should I administer the chewable tablets?

You should chew or crush the tablets completely before swallowing.

What is the maximum dosage for children?

Do not use more than 4 times a day, and if needed, repeat the dose every 6-8 hours.

What should I do if my child has a history of stomach problems?

Consult a doctor before using ibuprofen if your child has a history of stomach problems, such as heartburn.

What are the signs of a severe allergic reaction to ibuprofen?

Signs may include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, or blisters. Seek medical help immediately if these occur.

What should I do if my child experiences stomach bleeding?

Stop use and ask a doctor if your child feels faint, vomits blood, has bloody or black stools, or has stomach pain that does not improve.

Can ibuprofen be used before or after heart surgery?

No, do not use ibuprofen right before or after heart surgery.

What should I do if my child does not get relief within 24 hours?

If your child does not get any relief within the first day of treatment, consult a doctor.

Is there any specific information about using ibuprofen during pregnancy?

The provided text does not mention any specific statements regarding the use of ibuprofen during pregnancy.

Packaging Info

Below are the non-prescription pack sizes of Childrens Ibuprofen (ibuprofen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Childrens Ibuprofen.
Details

Drug Information (PDF)

This file contains official product information for Childrens Ibuprofen, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

Ibuprofen is the active ingredient in this formulation, which is presented as chewable tablets containing 100 mg of ibuprofen per tablet. This nonsteroidal anti-inflammatory drug (NSAID) is indicated for use as a pain reliever and fever reducer. The tablets are designed to be chewed or crushed completely before swallowing, ensuring effective administration. The duration of effect is up to 8 hours. These tablets are grape-flavored and are packaged in a container containing 24 tablets.

Uses and Indications

This drug is indicated for the reduction of fever and the relief of minor aches and pains associated with conditions such as the common cold, influenza, sore throat, headaches, and toothaches.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Tablets should be chewed or crushed completely before swallowing. This product does not provide directions or complete warnings for adult use. Healthcare professionals are advised to ensure that patients do not exceed the recommended dosage.

Dosing should be determined using the chart provided below. When possible, weight should be used to determine the appropriate dose; if weight is not available, age may be used as an alternative. If necessary, doses may be repeated every 6 to 8 hours, but it is important not to exceed a maximum of 4 doses in a 24-hour period.

Dosing Chart:

  • For patients weighing less than 24 lb or under 2 years of age: Tablets - consult a doctor.

  • For patients weighing 24-35 lb or aged 2-3 years: Tablets - 1.

  • For patients weighing 36-47 lb or aged 4-5 years: Tablets - 1 ½.

  • For patients weighing 48-59 lb or aged 6-8 years: Tablets - 2.

  • For patients weighing 60-71 lb or aged 9-10 years: Tablets - 2 ½.

  • For patients weighing 72-95 lb or aged 11 years: Tablets - 3.

It is crucial to adhere strictly to these guidelines to ensure safe and effective use of the product.

Contraindications

Use is contraindicated in patients with a history of allergic reactions to ibuprofen or any other pain reliever or fever reducer. Additionally, administration is contraindicated in the perioperative period surrounding heart surgery due to potential complications.

Warnings and Precautions

Ibuprofen may induce severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms indicative of an allergic response may include hives, facial swelling, wheezing, shock, skin reddening, rash, and blisters. In the event of an allergic reaction, it is imperative to discontinue use immediately and seek medical assistance.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries a risk of severe stomach bleeding. The likelihood of this adverse effect is heightened in pediatric patients with a history of stomach ulcers or bleeding disorders, those concurrently using anticoagulants or steroid medications, or those taking other NSAIDs, whether prescription or over-the-counter (e.g., aspirin, ibuprofen, naproxen). Additionally, exceeding the recommended dosage or duration of treatment increases this risk.

Healthcare professionals should be aware that the use of NSAIDs, excluding aspirin, is associated with an elevated risk of heart attack, heart failure, and stroke, which can be fatal. This risk is particularly pronounced when the medication is used in excess of the recommended dosage or for prolonged periods.

Severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, or vomiting, may indicate a serious condition. In such cases, it is essential to consult a physician promptly. The use of ibuprofen should not exceed two days, nor should it be administered to children under three years of age unless specifically directed by a healthcare provider.

In the event of an overdose, immediate medical attention is required. Healthcare providers should advise patients to contact a Poison Control Center (1-800-222-1222) without delay.

Healthcare professionals should instruct caregivers to discontinue use and seek medical advice if the child exhibits any signs of stomach bleeding, such as feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain. Additionally, symptoms suggestive of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, warrant immediate medical evaluation. If the child does not experience relief within the first 24 hours of treatment, or if fever or pain worsens or persists beyond three days, or if redness or swelling occurs in the affected area, further medical consultation is necessary. Any new or unusual symptoms should also prompt a discussion with a healthcare provider.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this product. Serious adverse reactions include severe allergic reactions, which may manifest as hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, or blisters, particularly in individuals with a known allergy to aspirin.

The use of this product, which contains a nonsteroidal anti-inflammatory drug (NSAID), carries a warning for severe stomach bleeding. The risk of this serious adverse reaction is heightened in patients with a history of stomach ulcers or bleeding problems, those taking anticoagulants or steroid medications, and individuals using other NSAIDs, including aspirin and naproxen. Patients should be advised to adhere strictly to dosing instructions, as prolonged use or exceeding the recommended dosage increases the risk of stomach bleeding.

Additionally, NSAIDs, excluding aspirin, are associated with an increased risk of heart attack, heart failure, and stroke, which can be fatal. This risk is particularly pronounced in patients who use the medication beyond the directed duration or dosage.

Common adverse reactions may include mouth or throat burning, which can be mitigated by administering the product with food or water. Patients should be monitored for signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Symptoms indicative of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, warrant immediate medical attention.

Patients are advised to consult a healthcare professional before use if they have a history of stomach problems, are experiencing dehydration, or have pre-existing conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. It is also recommended that patients under a doctor's care for serious conditions or those taking other medications seek guidance prior to using this product.

If symptoms do not improve within 24 hours, or if fever or pain worsens or persists beyond three days, patients should discontinue use and consult a healthcare provider. Redness or swelling in the painful area or the emergence of new symptoms should also prompt a consultation with a healthcare professional.

Drug Interactions

Ibuprofen may interact with various medications, leading to significant clinical effects.

Pharmacodynamic Interactions:The concomitant use of ibuprofen with anticoagulants or steroid medications may elevate the risk of gastrointestinal bleeding. Healthcare professionals should monitor patients closely for signs of bleeding and consider alternative pain management strategies if necessary.

Additionally, the use of nonsteroidal anti-inflammatory drugs (NSAIDs), including ibuprofen, has been associated with an increased risk of cardiovascular events such as heart attack, heart failure, and stroke. This risk is particularly pronounced when NSAIDs are used at higher doses or for extended periods. It is advisable to use the lowest effective dose for the shortest duration necessary to mitigate these risks.

Pharmacokinetic Interactions:Ibuprofen should not be administered concurrently with other NSAIDs, whether prescription or nonprescription, such as aspirin or naproxen. The combination of these agents may lead to an increased risk of adverse effects without providing additional therapeutic benefit.

No specific laboratory test interactions have been identified in the available data.

Packaging & NDC

Below are the non-prescription pack sizes of Childrens Ibuprofen (ibuprofen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Childrens Ibuprofen.
Details

Pediatric Use

Pediatric patients under 3 years of age should not use this medication unless directed by a doctor. For dosing, the following guidelines apply based on weight and age:

  • For patients weighing under 24 lb and under 2 years of age, consultation with a doctor is required.

  • For patients weighing 24-35 lb (ages 2-3 years), the recommended dose is 1 tablet.

  • For patients weighing 36-47 lb (ages 4-5 years), the recommended dose is 1 ½ tablets.

  • For patients weighing 48-59 lb (ages 6-8 years), the recommended dose is 2 tablets.

  • For patients weighing 60-71 lb (ages 9-10 years), the recommended dose is 2 ½ tablets.

  • For patients weighing 72-95 lb (age 11 years), the recommended dose is 3 tablets.

Healthcare professionals should advise parents to consult a doctor if the child has a history of stomach problems, such as heartburn, or if the child has high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or is taking a diuretic. Additionally, consultation is necessary if the child is under a doctor's care for any serious condition.

Dosing should not exceed the recommended amount, and if needed, doses may be repeated every 6-8 hours, with a maximum of 4 doses per day. Parents should seek medical advice if the child does not experience relief within the first 24 hours of treatment, or if fever or pain worsens or persists for more than 3 days.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. Monitoring for potential adverse effects is advisable, given the lack of targeted data for this population.

Pregnancy

There are no specific statements regarding the use of ibuprofen during pregnancy in the provided information. The prescribing information does not mention any contraindications or risks associated with ibuprofen use during this period. Additionally, no dosage modifications for pregnant individuals are provided, nor are there any special precautions outlined regarding the use of ibuprofen during pregnancy. Healthcare professionals should consider the absence of specific data when advising pregnant patients and weigh the potential benefits against any unknown risks.

Lactation

There are no specific statements regarding the use of this medication in lactating mothers or its effects on breastfed infants. Healthcare professionals should consider the absence of data when advising lactating mothers about the use of this medication.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have a history of kidney disease. It is essential to assess the patient's overall health status, including any comorbid conditions such as high blood pressure, heart disease, liver cirrhosis, or a history of stroke, as these factors may influence the management of their renal function and the appropriateness of treatment. Monitoring and potential dosing adjustments may be necessary based on the patient's renal status to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment may experience altered pharmacokinetics of the medication due to compromised liver function. It is essential to assess the severity of liver impairment before initiating treatment.

In patients with liver cirrhosis, dosage adjustments may be necessary to avoid potential toxicity. Close monitoring of liver function tests, including alanine aminotransferase (ALT), aspartate aminotransferase (AST), and bilirubin levels, is recommended throughout the treatment course.

Additionally, patients with a history of significant liver disease, such as cirrhosis, should be evaluated for any contraindications related to their hepatic condition. Careful consideration should be given to the overall health status of these patients, particularly if they also present with comorbidities such as high blood pressure, heart disease, or kidney disease.

Regular follow-up and reassessment of liver function are crucial to ensure the safe and effective use of the medication in this population.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Healthcare professionals should advise patients or caregivers to call the Poison Control Center at 1-800-222-1222 for guidance.

Prompt intervention is crucial in managing overdose situations, as timely medical support can significantly influence outcomes. Symptoms of overdose may vary depending on the substance involved and the individual’s health status. Therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures may include supportive care, symptomatic treatment, and specific antidotes if applicable. Healthcare providers should remain vigilant and prepared to implement appropriate interventions based on the clinical presentation of the patient.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the compound in these areas.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. These events have been documented in the context of postmarketing surveillance and should be considered when evaluating the safety profile of the product.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose.

Patients should be informed that they may experience burning sensations in the mouth or throat when taking the medication. To mitigate this, it is recommended that the medication be taken with food or water. Additionally, if patients experience stomach upset, they should take the medication with food or milk to help alleviate discomfort.

Storage and Handling

The product is supplied in a configuration that includes an NDC number for identification. It should be stored at a temperature range of 20-25°C (68-77°F) to maintain its integrity and efficacy.

Healthcare professionals are advised to inspect the product prior to use; it should not be utilized if the printed seal under the cap is broken or missing, as this may indicate potential tampering or contamination. Proper handling and storage conditions are essential to ensure the product remains safe and effective for patient use.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Childrens Ibuprofen, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Childrens Ibuprofen, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

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Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.